Multi-functional medical catheter and methods of use

ABSTRACT

The present invention provides multi-functional medical catheters, systems and methods for their use. In one particular embodiment, a medical catheter ( 100 ) includes a flexible elongate body ( 105 ) having a proximal end ( 110 ) and a distal end ( 120 ). A plurality of spaced apart electrodes ( 130–136 ) are operably attached to the flexible body near the distal end. At least some of the electrodes are adapted for mapping a tissue and, in some embodiments, at least one of the electrodes is adapted for ablating a desired portion of the tissue. The catheter includes a plurality of tissue orientation detectors ( 140–146 ) disposed between at least some of the electrodes. In this manner, the medical catheter is capable of tissue mapping, tissue imaging, tissue orientation, and/or tissue treatment functions.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a Continuation-in-Part (CIP) of U.S. patentapplication Ser. No. 10/305,256, filed Nov. 25, 2002, and entitled“ULTRASOUND-GUIDED ABLATION CATHETER AND METHODS OF USE;” now U.S. Pat.No. 6,824,515, which is a continuation of U.S. application Ser. No.09/750,439, filed on Dec. 28, 2000, and issued on Jan. 21, 2003 as U.S.Pat. No. 6,508,765; which is a continuation of U.S. application Ser. No.09/227,281, filed Jan. 6, 1999 and issued on Mar. 27, 2001 as U.S. Pat.No. 6,206,831 B1, the complete disclosures of which are incorporatedherein by reference for all purposes.

BACKGROUND OF THE INVENTION

The invention relates generally to the field of medical catheters, andin particular, to multi-functional medical catheters adapted to map,orient and/or provide treatment for a variety of medical conditions.

Physicians make use of catheters today in medical procedures that arebest performed by gaining access into interior regions of the body. Forexample, in electrophysiological therapy, ablation is used to treatcardiac rhythm disturbances. Such a therapy may be used, for instance,to treat atrial fibrillation by forming lesions in heart tissue atdesired locations to interrupt undesirable electrical pathways.

During these procedures, the physician typically first maps theelectrical activity of the patient's heart to help determine thelocation of any abnormalities. The physician then steers a catheterthrough a main vein or artery into the interior region of the heart thatis to be treated. An ablation element carried on the distal end of thecatheter is positioned near the tissue that is to be ablated. For suchtreatments, the delivery of ablating energy must be closely governed toavoid incidence of tissue damage and coagulum formation. Further, theablation catheters must be precisely positioned adjacent to andpreferably in contact with the tissue to be treated, to insure thelesions are properly located.

Physicians and staff performing diagnostic and therapeutic procedures,such as electrophysiological therapy, typically require an imagingsystem to assist them in positioning the ablation catheter.Mini-transesophageal echocardiography (mini-TEE) probes are available,however, these probes must be swallowed or inserted down the patient'sthroat. Such probes are poorly tolerated by patients unless they arefully anesthetized. Further, these probes can be rather large (i.e., 20French in diameter), use complex transducer configurations and may havedifficulty in detecting tissue contact by the ablation elements.Further, the mapping, imaging and treatment often requires multipleinstruments or catheters, involving complex procedures as well as theintroduction or reintroduction of multiple catheters into the patient.Improvements are desired.

BRIEF SUMMARY OF THE INVENTION

The present invention provides multi-functional medical catheters,systems and methods for their use. In some embodiments, the cathetersinclude ultrasound-guided ablation catheters. Catheters and systems ofthe present invention will be particularly useful for precisepositioning of ablation catheters prior to ablation of cardiac tissue,such as that required for the treatment of atrial fibrillation. Further,the functionality of some of the embodiments permits a single catheterto be used for tissue mapping, tissue orientation, tissue imaging,and/or tissue treatment, including ablation. Some of the systems of thepresent invention use transducers in the distal end of the catheter toassist the operator in determining whether or not the ablation elementsare in contact with the tissue to be ablated. Non-ablation cathetersalso fall within the scope of the present invention, with such cathetersproviding tissue mapping, tissue orientation and/or tissue imagingfunctions.

In one particular embodiment, a medical catheter of the presentinvention includes a flexible elongate body having a proximal end and adistal end. A plurality of spaced apart electrodes are operably attachedto the flexible body near the distal end. At least some of theelectrodes are adapted for mapping a tissue. The catheter includes aplurality of tissue orientation detectors disposed between at least someof the electrodes. In this manner, the medical catheter is capable ofboth tissue mapping and tissue orientation functions. In someembodiments, at least one of the electrodes is adapted for ablating adesired portion of the tissue, with the catheter capable of tissueablation or other treatments.

In some aspects, at least one of the electrodes is adapted for bothmapping and ablation. In some aspects, the electrodes adapted forablating have at least one tissue orientation detector adjacent thereto.In such a manner, the detector(s) help determine the location of theablation electrode prior to ablation. For example, the detectors mayoperate to determine tissue contact, to detect a distance to the tissue,to detect a three-dimensional position relative to the tissue, and thelike. In some aspects, at least one of the electrodes includes a tipelectrode coupled to a tip of the distal end.

The tissue orientation detectors may have a variety of configurationswithin the scope of the present invention. For example, in oneembodiment the tissue orientation detectors include a plurality oftransducers. In a particular embodiment, at least some of thetransducers include ultrasound transducers. Alternatively, or inaddition, at least some of the transducers are electric, magnetic, orelectromagnetic tracking transducers.

The present invention further provides exemplary medical cathetersystems according to the present invention. In one embodiment, thesystem includes a medical catheter like those detailed herein, with acontroller coupled to the plurality of electrodes and tissue orientationdetectors. In one aspect, the controller is adapted for controlling atissue mapping function performed by the plurality of electrodes. In aparticular aspect, the tissue mapping function includes a non-contacttissue mapping function. In one aspect, the controller is furtheradapted for determining a tissue ablation pattern based on a result ofthe tissue mapping function.

In another aspect, the medical catheter system controller is adapted forreceiving a plurality of signals from the tissue orientation detectorsand determining an orientation of the elongate body relative to thetissue.

In some embodiments, the medical catheter system further includes adigitizing system, and/or an RF generator electrically coupled to theplurality of electrodes. The digitizing system is adapted for producinga digitized image of the tissue. These images may be based in part onthe data received by the electrodes and/or the detectors. The RFgenerator may facilitate using one or more electrodes to ablate tissue,or the like.

The present invention further provides exemplary methods of preciselypositioning a medical catheter with respect to a tissue. In one suchembodiment, the method includes providing a medical catheter system,such as one of the systems detailed herein. The method further includesinserting the flexible elongate body into a patient, mapping anelectrical profile of the tissue using at least some of the electrodes,and positioning the elongate body to be proximate a tissue using thetissue orientation detectors. The positioning is based at least in parton the electrical profile of the tissue.

In one aspect, the method further includes activating at least one ofthe electrodes to ablate a desired region of the tissue if thecontroller determines that at least one of the tissue orientationdetectors is in contact with the desired region. In particular aspects,at least one of the electrodes is activated to ablate a desired regionof the tissue if the controller determines that one of the tissueorientation detectors located adjacent the electrode is in contact withthe desired region, if the tissue orientation detector located directlyproximal of the electrode is in contact with the tissue, and/or if thetissue orientation detectors closest to the electrode in both theproximal and distal directions are in contact with the tissue. In thismanner, tissue contact may be determined prior to ablation.

In one aspect, methods of the present invention further includeidentifying a desired region of the tissue to be treated based on theelectrical profile of the tissue. As discussed herein, the mapping mayinclude a non-contact mapping in some embodiments to obtain or helpobtain the electrical profile.

In another method of precisely positioning a catheter within a patientaccording to the present invention, the catheter is inserted into thepatient. The method then includes mapping a tissue of the patient, usingat least some of the plurality of spaced apart electrodes, to produce atissue profile. The tissue profile may include, for example, a map orother depiction of a plurality of electrical pathways in the tissue. Atissue region to be treated is identified by using, at least in part,the tissue profile. The elongate body is positioned using thetransducers so that at least one of the electrodes is proximate thetissue region. In one aspect, the elongate body positioning includes athree-dimensional localization positioning. The electrode(s) may befurther operated to ablate the tissue region where desired to providetreatment to the patient.

In another embodiment of the present invention, a method of diagnosingand treating cardiac rhythm disturbances includes inserting a catheterinto a patient, and mapping a tissue of the patient, using at least someof the plurality of spaced apart electrodes, to produce a tissueprofile. The method includes identifying a tissue to be treated usingthe tissue profile, positioning the elongate body using the tissueorientation detectors so that at least one of the electrodes isproximate the tissue to be treated, and treating the tissue using thecatheter. The treatment may include ablating the tissue using at leastone electrode. Ablation may occur through the use of RF ablation,through ultrasound ablation, or the like. An exemplary description ofacoustic ablation using transducer elements is described in U.S. Pat.No. 5,630,837, the complete disclosure of which is hereby incorporatedby reference for all purposes. It will be appreciated by those skilledin the art that other ablation elements may be used within the scope ofthe present invention.

Other features and advantages of the invention will appear from thefollowing description in which the preferred embodiment has been setforth in detail in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an overall view of a system for ablating tissue accordingto an embodiment of the present invention;

FIG. 2 depicts the distal end of a flexible elongate body as part of acatheter system according to an embodiment of the present invention;

FIG. 3 depicts a cross-sectional side view of the flexible elongate bodyshown in FIG. 2;

FIG. 4A depicts a cross-sectional end view of the flexible body shown inFIG. 3 taken along line 4A—4A;

FIG. 4B depicts an overall view of a cylindrical transducer element aspart of a catheter apparatus according to an embodiment of the presentinvention;

FIGS. 5A and 5B depict alternative embodiments of a medical catheterapparatus according to the present invention;

FIG. 6 depicts a schematic of a multiplexer for use with medicalcatheters of the present invention;

FIGS. 7A–7B depict energizing and reflected signals sent to and receivedby a transducer element of the present invention;

FIG. 8 depicts an embodiment of a medical catheter apparatus of thepresent invention in contact with tissue;

FIG. 9 is an overall view of a medical catheter according to analternative embodiment of the present invention;

FIG. 10 is a simplified overall view of a medical catheter systemaccording to an embodiment of the present invention;

FIG. 11 is a simplified flow chart of a method of the present invention;and

FIGS. 12A and 12B depict a simplified overall view and a cross-sectionalside view of an alternative embodiment of a catheter according to thepresent invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 depicts a medical catheter apparatus 2 as part of a cathetersystem 4 according to an embodiment of the present invention. Apparatus2 comprises a flexible elongate body 12 having a distal end 10 and aproximal end 14. Proximal end 14 includes a handle 16 containing asteering mechanism 18. Steering mechanism 18 includes a steering lever22 which operates a cam wheel (not shown) to maneuver flexible distalend 10 as shown by the arrows in FIG. 1. System 4 includes a connector20 which connects with a controller 23 for operation of apparatus 2 asfurther described below. Controller 23 is capable of providingelectrical input to apparatus 2 as needed to map, image, orient, and/orablate a patient tissue. It will be appreciated by those skilled in theart that steering mechanism 18 can vary from that shown in FIG. 1 withinthe scope of the present invention. Exemplary steering mechanisms aredescribed in International Application No. PCT/US94/11748, the completedisclosure of which is incorporated herein by reference for allpurposes.

Medical catheter apparatus 2 depicted in FIG. 1 will be particularlyuseful in the treatment of atrial fibrillation by positioning distal end10 within a desired region of the heart. To enter the right atrium, thephysician can direct elongate body 12 through a conventional vascularintroducer through the femoral vein. For entry into the left atrium, thephysician can direct elongate body 12 through a conventional vascularintroducer retrograde through the aortic and mitral valves. For thetreatment of atrial fibrillation, it is believed that formation oflesions in the heart muscle tissue is required. Catheters of the presentinvention may be used, in some embodiments, to ablate heart tissuecontaining abnormal electrical pathways, such as arrhythmogenic foci.Further details of apparatus 2 are shown in FIGS. 2 and 3.

FIGS. 2 and 3 depict elongate body 12 having a plurality of spaced-apartablation elements 24, each separated by a gap 26 from adjacent ablationelements 24. Interspaced amongst ablation elements 24 are a plurality oftransducer elements 28. In one embodiment, ablation elements 24 andtransducer elements 28 are operably attached to body 12 in analternating fashion. Apparatus 2 preferably includes between about two(2) and about fourteen (14) ablation elements, and between about three(3) and about fifteen (15) transducer elements. More preferably,apparatus 2 has at least one more transducer element 28 than ablationelements 24. In one embodiment, a temperature sensor 30 is provided ator near distal end 10 and a proximal temperature sensor 32 is providedproximal to ablation elements 24. Temperature sensors 30 and 32preferably comprise thermocouples. Temperature sensors 30 and 32 alsomay comprise thermistors and the like within the scope of the presentinvention. Temperature sensors or thermocouples 30 and 32 operate todetect the temperature in the region of ablation. A plurality ofinsulators 40 are provided between transducer elements 28 and ablationelements 24. Insulators 40 may comprise polyimide, polyesters, teflon orthe like to insulate transducer elements 28 from ablation elements 24.

In one embodiment, transducer elements 28 comprise cylindricaltransducer elements as best shown in FIGS. 4A–4B. Transducer elements 28include an outer face 46 and an inner face 48. Inner faces 48 oftransducer elements 28 are positioned such that a longitudinal axis 38of body 12 passes through a throughhole 44 of each transducer element28. In such a manner, transducer elements 28 are configured to exposeouter faces 46 to surrounding tissue and fluid within the patient. Inthis manner, transducer elements 28 may operate to image within athree-hundred and sixty degree (360°) plane that is generallyperpendicular to longitudinal axis 38 without the need to rotate body 12or transducers 28. It will be appreciated by those skilled in the artthat other transducer shapes may be used within the scope of the presentinvention. For example, transducer elements 28 may comprise rectangularor elliptical transducer elements operably attached to distal end 10.

Transducer elements 28 may comprise ultrasound transducers. In thisembodiment, transducer elements 28 may comprise piezocompositematerials, piezoceramics (such as PZT), piezoplastics, and the like.Alternatively, as further detailed below, transducer elements 28 may beadapted to transduce between a magnetic field and a voltage. Othertransducer types also may be used within the scope of the presentinvention, including without limitation, electric, magnetic,electromagnetic, permanent magnets, wireless, optical, and the like.

In the embodiment shown in FIG. 3, transducers 28 comprise ultrasoundtransducer elements 28. Transducers 28 each may include a matching layer42, or multiple matching layers 42, operably attached to the outer face46 of each transducer element 28. Matching layers 42 operate to improvetransducer element 28 performance. Transducer elements 28 also canoperate without matching layers 42 within the scope of the presentinvention.

Transducer elements 28 have an outer diameter 29. Outer diameter 29 canbe less than an outer diameter 31 of flexible elongate body 12 or,alternatively, about equal to diameter 31. Preferably, diameter 31 ofbody 12 is less than about eight (8) French to permit the introductionof apparatus 2 into a patient's tortuous vasculature.

Gap 26 separates adjacent ablation elements 24. Gap 26 preferably isbetween about 1.5 mm and about 3.0 mm in width. Gap 26, however, can belarger or smaller in size and need not be of uniform size between eachtwo adjacent ablation elements 24. Similarly, each gap 26 need notcontain a transducer element 28, and gap 26 may contain more than onetransducer element 28 within the scope of the present invention.However, preferably at least some gaps 26 contain transducer elements28, and in some embodiments, each gap 26 between ablation elements 24contains at least one transducer element 28.

Elongate body 12 preferably includes a working lumen 39 through whichlongitudinal axis 38 passes. As best shown in FIG. 4A, matching layer 42extends around the outer surface of transducer element 28. Matchinglayer 42 is operably attached to transducer element 28, preferably usingepoxy or the like. Transducer element 28 can be operably attached toelongate body 12 in a variety of manners, including by epoxy. The use oflumen 39 is best shown in FIGS. 5A and 5B which depict two alternativeembodiments of apparatus 2 of the present invention.

FIG. 5A depicts the medical catheter apparatus shown in FIG. 3 withoutmatching layers 42. As can be seen in FIG. 5A, a plurality of leads 50are operably attached to thermocouples 30 and 32, to transducer elements28 and to ablation elements 24. For an embodiment having electrodes forablation elements 24, each electrode has a single lead 50. Thermocouples30 and 32 each have a pair of leads 50. Transducer elements 28 have onelead 50 in electrical communication with outer face 46. Further, aground 52 extends from inner face 48 of transducer 28. As shown in FIG.5A, a common ground can be used for all transducer elements 28 within aparticular apparatus 2. One benefit of using a common ground 52 is thatfewer leads or wires 50 are passed from distal end 10, through lumen 39to controller 23.

The embodiment shown in FIG. 5B depicts the use of a multiplexer 54operably attached to distal end 10 of flexible elongate body 12.Multiplexer 54 preferably is disposed proximal of ablation elements 24and transducer elements 28. Multiplexer 54 permits the attachment ofleads 50 from transducer elements 28 to multiplexer 54 without the needto run those leads 50 to controller 23. Such a configuration can reducethe number of wires needed to be extended through lumen 39 to controller23.

The operation of multiplexer 54 is best described in conjunction withFIG. 6. FIG. 6 depicts transducer elements 28 each having ground 52 andlead 50. Leads 50 are operably attached to multiplexer 54, preferably onthe distal side of multiplexer 54. Multiplexer 54 has a ground 62 and atransmission line 60 for providing power to multiplexer circuit 54.Transmit and receive lines 56 provide a means to transmit electricalsignals to multiplexer 54. Multiplexer 54 then directs electricalsignals to the appropriate transducer(s) 28. Transmit/receive wires 56carry transducer 28 excitation signals as differential pulses in seriesformat from controller 23 to multiplexer 54. At multiplexer 54, eachexcitation signal is routed to an appropriate one of the transducerelements 28 in order to execute an excitation sequence used bycontroller 23. Similarly, return inputs or echoes received by transducerelement(s) 28 are transferred to multiplexer 54 and return to controller23 along transmit/receive lines 56.

By minimizing the number of wires required to carry the excitationsignals from controller 23 to each of transducer elements 28, thediameter of elongate body 12, and more specifically, the size of lumen39 can be reduced. Alternatively or in addition, the number oftransducer elements 28 can be increased at distal end 10 without theneed to require wires to be run through lumen 39 to controller 23.

Multiplexer 54 further may include a clock line 58 extending fromcontroller 23 to multiplexer 54. Clock line 58 assists multiplexer 54 indetermining which transducer element 28 is to receive an excitationsignal. Alternatively, as shown in FIG. 6, clock line 58 operates bycounting the number of excitation signals transmitted throughtransmit/receive lines 56 and incrementing a counter in multiplexer 54to coordinate the transfer of excitation signals to the appropriatetransducer 28. In one embodiment, multiplexer 54 also includes a dataline (not shown in FIG. 6) extending from controller 23 to multiplexer54. This data line permits controller 23 to control the operation ofmultiplexer 54.

Turning now to FIGS. 7 and 8, the operation of medical catheterapparatus 2 and system 4 according to an embodiment of the presentinvention will be described. Medical catheter apparatus 2 operates byhaving transducer elements 28 detect the proximity of a tissue 70 withrespect to elongate body 12 distal end 10. Controller 23 calculates thetime delay between transducer element 28 excitation and the receipt of areflected signal 66 from surrounding tissue 70 to determine the distancebetween transducer element 28 and tissue 70, as further described below.

As shown by FIGS. 7A and 7B, an excitation signal 64 is transmitted fromcontroller 23 to transducer elements 28, or to multiplexer 54 fortransmission to transducer elements 28. Excitation signal 64 isconverted by transducer 28 into an ultrasound signal which propagatesout into surrounding fluid and tissues within the patient. Transducerelements 28 detect reflected signals 66 and transfer electricalrepresentations of those signals to controller 23 for processing.

Controller 23 uses the time delay between the excitation 64 and thereceipt of reflected signal 66 to calculate the approximate distance tothe reflecting object. Controller 23 is capable of differentiatingbetween low amplitude blood reflections and larger amplitude tissuereflections 66 as shown in FIG. 7. Controller 23 further differentiatesfrom a randomized back scatter versus more stable tissue scatter. Thedistance from each transducer 28 to tissue 70 may be calculated byknowing the speed of sound and measuring the time response to the largeramplitude tissue reflections. If the signal completely consists oflarger amplitude wave forms, intimate contact will be diagnosed. Whiletransducers 28 inherently have a blind zone/time period in which signalscannot be measured, the resulting blind zone distance is rather small.For example, for a 30 Mhz transducer, this distance is approximately0.15 mm. Hence, reflected signal 66 measured almost immediately afterexcitation 64 occurs results in the distance from the transducer 28 totissue 70 being less than about 0.15 mm blind distance.

Medical catheter system 4, therefore, can be operated by insertingapparatus 2 into the patient and positioning distal end 10 of apparatus2 near a desired location of the patient's anatomy. Transducer elements28 are energized with excitation signal 64 and reflected signals 66 arereceived and processed by controller 23. Controller 23 determineswhether or not transducer elements 28 are in contact with tissue 70. Ifat least one transducer element 28 is in contact with tissue 70,ablation using an adjacent ablation element 24 may occur. Preferably, asshown in FIG. 8, it will be desirable to have more than one transducerelement 28 in contact with tissue 70.

Controller 23 can be operated in a variety of ways to determine thenumber and positioning of transducer elements 28 which may be in contactwith tissue 70. For example, as shown in FIG. 8, transducer elements28A, 28B and 28C would indicate that they were in contact with tissue70. This may permit the physician to ablate tissue 70 using electrode24A and electrode 24B. Transducer element 28D would not indicate contactwith tissue 70. Therefore, it is inconclusive whether ablation element24C is in contact with tissue 70. Hence, the physician may choose not toablate with ablation element 24C.

In one embodiment, controller 23 may use a green and red light systemfor indicating when transducer elements 28 are in contact with tissue70. In one particular embodiment, for example, controller 23 has a redlight and a green light for each transducer element 28A–28D depicted inFIG. 8. The green light would be illuminated by controller 23 when thecorresponding transducer element 28 is in contact with tissue 70. Redlights would be illuminated for those transducer elements 28 not intissue contact.

Alternatively, a single green and red light may be used for apparatus 2,whereby the green light is illuminated by controller 23 only when alltransducer elements 28 are in tissue contact. Still another embodimentinvolves several transducer elements 28 corresponding to a singlegreen/red light set. For example, elements 28A and 28B may have onegreen light which controller 23 illuminates when both elements 28A and28B are in tissue contact. The red light corresponding to elements 28Aand 28B would be illuminated if one or both transducer elements 28A and28B are not in contact with tissue 70. It will be appreciated by thoseskilled in the art that there exist numerous ways within the scope ofthe present invention for controller 23 to indicate when tissue 70contact has been achieved by transducer elements 28, including audibletones and the like.

Ablation elements 24 are preferably used for mono-polar ablation,although bi-polar ablation also is anticipated within the scope of thepresent invention. Ablation elements 24 preferably comprise electrodes.In this manner, RF ablation may occur using ablation elements 24.

Alternatively, ablation elements 24 may comprise ablation ultrasoundtransducers. In this manner, transducer elements 28 are operated inpulse mode to determine their distance from tissue 70. Upon tissuecontact, ablation transducers 24 would be used to ablate tissue 70. Theuse of transducers for acoustic ablation is further described in U.S.Pat. No. 5,630,837, the complete disclosure of which has been previouslyincorporated herein by reference.

Alternatively, transducer elements 28 can be used to both image andablate tissue 70. Transducer elements 28 would first be operated inpulse mode, to determine whether transducer elements 28 are in contactwith tissue 70. Transducer elements 28 then would receive a continuouswave or gated continuous wave electrical signal having a frequency ofabout 10–15 MHz, and transducer elements 28 would ablate tissue 70 usingultrasound ablation.

Turning now to FIGS. 9 and 10, an alternative embodiment of a medicalcatheter 100, and a medical catheter system 200 according to the presentinvention will be described. Medical catheter 100 includes an elongatebody 105 having a proximal end 110 and a distal end 120. Proximal end110 is coupled to a steering device 210 as shown in FIG. 10. Steeringdevice 210 may, but need not be similar to that described in conjunctionwith FIG. 1. The length of catheter 100 may vary within the scope of thepresent invention. In one embodiment, the length of catheter 100 issufficient to permit insertion into the femoral vein in a patient legand traverse through the patient vasculature to reach the heart muscleor other region to be treated. Distal end 120, as best shown in FIG. 9,includes a plurality of elements coupled to or otherwise disposedtherewith for tissue mapping, tissue orientation detection, tissueimaging, tissue treatment, and the like. In the embodiment shown in FIG.9, distal end 120 includes a tip electrode 130 disposed at or near thedistal tip of catheter 100. In one embodiment, tip electrode 130provides an exemplary electrode for ablation treatments as previouslydescribed.

Catheter 100 includes a plurality of spaced apart electrodes 132, 134,and 136 coupled to distal end 120. In one embodiment, electrodes 132–136comprise ring electrodes. In a particular embodiment, ring electrodes134 and 136 operate as an electrode pair for a tissue mapping function.Further, electrodes 130 and 132 may operate as an electrode pair for atissue mapping function. Catheter 100 further includes a plurality oftissue orientation detectors 140, 142, 144, and 146 spaced alongelongate body 105. As shown in FIG. 9, tissue orientation detector 140is disposed near the distal tip of elongate body 105 such that detector140 is in close proximity to tip electrode 130. Similarly, detector 146is disposed proximal to the remaining elements of distal end 120, andmay be used for orientating or detecting the location of distal end 120.

Distal end 120 further includes a plurality of insulators 150.Insulators 150 are adapted to insulate electrodes 130–136 from oneanother, and/or to insulate detectors 140–146 from one another, and/orto insulate detectors 140–146 from electrodes 130–136. In a particularembodiment, each electrode 130–136 has at least one detector 140–146disposed adjacent thereto, with possibly an intervening insulator 150therebetween. For example, tip electrode 130 has detector 140 locatedproximal thereto. Electrode 132 has detector 140 located distal thereto,and detector 142 located proximal thereto. While electrodes 134 and 136are separated from one another by only an insulator 150, each electrode134 and 136 has an adjacent detector 142 and 144, respectively. In thismanner, detectors 140–146 and electrodes 130–136 may be used in concertfor a variety of procedures as further described herein. It will beappreciated by those skilled in the art that the orientation and orderof the various detectors 140–146, electrodes 130–136 and insulators 150may vary within the scope of the present invention.

In one embodiment, tissue orientation detectors 140–146 includetransducers. Transducers 140–146 may be adapted to transduce between avariety of physical parameters. For example, in one embodiment, at leastsome transducers 140–146 are adapted to transduce between ultrasoundenergy and a voltage. This may occur, for example, when one or more ofdetectors 140–146 comprise ultrasound transducers which are adapted totransmit an ultrasound energy wave when a voltage is applied acrossopposing surfaces of the detector 140–146. The ultrasound wave travelstowards a tissue 170, and is reflected by tissue 170. The reflected waveis received by detector 140–146, and is converted into a voltage bydetector 140–146. The voltage is transmitted to a controller 230, suchas is shown in FIG. 10. In this manner, detectors 140–146 transducebetween ultrasound energy and voltage. Alternatively, detectors 140–146may be adapted to transducer between a voltage and a magnetic field. Forexample, a magnetic or electromagnetic field generator can be placed inproximity to the patient. In one embodiment, the catheter carries one ormore transducers that detect the magnetic or electromagnetic field andconvert it into a voltage. The voltage is then supplied to controller230 for orientation detection purposes. Alternatively, other transducertypes may be used, including electrical transducers, permanent magnets,optical transducers, and the like.

Medical catheter 100 is adapted to perform one or more functions, andmay be adapted to image tissue, map tissue, assist in orienting itselfwith respect to tissue, treat tissue, and the like. For example,catheter 100 may be adapted for mapping a patient tissue, such as hearttissue. This may occur a number of ways within the scope of the presentinvention. For example, tissue orientation detectors 140–146 may be usedby inserting catheter 100 into a patient's vasculature and transferringdistal end 120 to a desired region of the patient. Catheter 100 then maybe used in conjunction with one or more reference catheters to perform athree-dimensional localization process to help map the general shape ofthe patient's tissue, such as the heart muscle. Details of athree-dimensional localization process are further described in U.S.Pat. No. 6,490,474, entitled “System and Method for ElectrodeLocalization Using Ultrasound,” the complete disclosure of which isincorporated herein by reference for all purposes.

In an alternative embodiment, catheter 100 is used to map the electricalactivity of tissue 170. For example, in one embodiment, catheter 100 isinserted into a desired region of the patient, and positioned such thatone or more electrodes 130–136 are in contact with tissue 170. Tissuemapping procedures may then be performed to map the electrical activityof the heart muscle. Such electrode mapping techniques are furtherdescribed in U.S. Pat. Nos. 5,598,848, entitled “Systems and Methods forPositioning Multiple Electrode Structures in Electrical Contact with theMyocardium”; U.S. Pat. No. 5,487,391, entitled “Systems and Methods forDeriving and Displaying the Propagation Velocities of Electrical Eventsin the Heart”; and U.S. Pat. No. 6,516,807, entitled “System and Methodsfor Locating and Guiding Operative Elements within Interior BodyRegions,” the complete disclosures of which are incorporated herein byreference for all purposes.

While the above-noted references discuss the use of a basket catheterfor placing electrodes in contact with heart tissue to be mapped, thepresent invention may be adapted to insure tissue contact prior tomapping. For example, the techniques discussed in conjunction with FIGS.1–8 may be used, including the time delay of ultrasound signalstransmitted by, and subsequently received by detectors 140–146, toverify tissue contact.

In an alternative embodiment, catheter 100 maps the electrical activityof tissue 170 using a non-contact mapping technique. Non-contact mappinguses electrodes 130–136 to sense electrical activity within tissue 170notwithstanding the fact there may be a gap 160 between electrode(s)130–136 and tissue 170. These far field signals received by electrodes130–136 are mapped onto the surface of tissue 170 using an algorithmwhich takes into account the relationship between distal end 120 andtissue 170, and the general orientation of catheter 100 with respect totissue 170. In this manner, electrically active tissue 170 is mapped.Additional details on mapping tissue, including non-contact mapping, maybe found in U.S. Pat. No. 6,240,307 entitled “Endocardial MappingSystem,” the complete disclosure of which is incorporated herein byreference.

Data received or generated by detectors 140–146, and/or electrodes130–136 may be optionally transmitted to controller 230 by couplingcatheter 100 to controller 230 using a cable 220 or other electricallyconductive medium. In one embodiment, controller 230 comprises amicroprocessor coupled to a computer readable storage medium havingsoftware or other programs adapted to perform a variety of procedures.Controller 230 may include an input device 250 for receipt of a compactdisc, a DVD, or the like containing reference data, algorithms orrelated processing software, or the like. In a particular embodiment,controller 230 further includes a light array 240 that is adapted tovisually indicate to the operator or physician when one or moredetectors 140–146 are in contact with tissue 170. As previouslydescribed, light array 240 may comprise a green/red light system, and/ormay include some other visual or audio indicator. In one embodiment,controller 230 includes a digitizer that is adapted to digitize the datareceived from catheter 100 and display an image of tissue 170 on amonitor 270. Controller 230 may be coupled to monitor 270 using a cable260 or the like. Alternatively, wireless connections may be used tocouple controller 230 with display 270 and/or to couple controller 230with catheter 100.

Turning now to FIG. 11, an embodiment of a method 300 of preciselypositioning catheter 100 according to the present invention will bedescribed. Method 300 includes inserting catheter 100 into a patient(block 310). As previously described, this may occur, for example, byinserting catheter 100 through the femoral vein of the patient. Catheter100 is then used to map tissue (block 320). The mapping of tissue 170may include three-dimensional localization techniques, and/or themapping of electrical activity within tissue 170, both as previouslydescribed. Method 300 further includes identifying a tissue region to betreated (block 330). This may occur, for example, by displaying an imageof tissue 170 on display 270 for review by a physician or other operatorof system 200.

Method 300 further includes positioning of elongate body 105 (block340). This may involve the various procedures as previously described,and may include the use of detectors 140–146 to orient catheter 100within the desired region of the patient. For example, detectors 140–146may be used to generally determine that distal end 120 is in the properregion of the patient. Further, the positioning of catheter 100 mayinclude using one or more detectors 140–146 to determine that tissue 170has been contacted. In another embodiment, electrodes 130–136 are usedto facilitate orientation of catheter 100. This may occur, for example,by receiving electrical signals from the heart and comparing theelectrical signals with a previously generated map of electrical signalsof tissue 170, such as that received as a result of the mapping oftissue in block 320. The comparison may assist in determining theorientation of catheter 100 relative to tissue 170.

Once catheter 100 has been precisely positioned, or if non-contacttechniques are employed once a cardiac map has been obtained, thephysician or operator of system 200 may optionally treat tissue 170(block 350). As previously discussed, one such treatment involves theablation of tissue 170, or a portion of tissue 170, such as may bedesired to treat atrial fibrillation. The treatment aspects of method300 may further include the delivery of medicines or other therapy totissue 170 instead of ablation. It will be appreciated by those skilledin the art that while method 300 is depicted and described as includinga series of processes, the procedures identified in FIG. 11 may occur inan order different than that shown. For example, the physician may havealready identified a tissue region to be treated. In this case, block330 may be removed from method 300. Further, the positioning of elongatebody in block 340 may occur prior to tissue mapping, and/or after tissuetreatment.

An alternative embodiment of a medical catheter according to the presentinvention will be described in conjunction with FIGS. 12A and 12B. Asshown, the catheter includes an elongate body 412 having a working lumen439 and a longitudinal axis 438. A plurality of spaced-apart electrodes424 are disposed on body 412. Interspaced amongst electrodes 424 are aplurality of tissue orientation detectors 428. In one embodiment, tissueorientation detectors 428 include transducer elements 428. Forembodiments in which orientation detectors 428 comprise transducers, andin particularly ultrasound transducers, detectors 428 may include one ormore matching layers 442 operably attached to the outer face 446 of atleast some of the detectors 428. Matching layers 442 operate to improvetransducer 428 performance. Detectors 428 also may operate withoutmatching layers 442 within the scope of the present invention. Further,while shown coupled to elongate body 412 in an alternating fashion, thearrangement of electrodes 424 and detectors 428 may vary within thescope of the present invention.

Detectors 428 have an outer diameter, which may be less than an outerdiameter 431 of flexible elongate body 412 or, alternatively, aboutequal to diameter 431. Preferably, diameter 431 of body 412 is less thanabout eight (8) French to permit the introduction of the medicalcatheter into a patient's tortuous vasculature. A plurality of gaps 426separate electrodes 424 and detectors 428 from each other and/or fromone another. Each gap 426 need not contain detector 428, and gaps 426may contain more than one detector 428 within the scope of the presentinvention. A plurality of insulators 440 are disposed between at leastsome orientation detectors 428 and/or electrodes 424. Insulators 440 maycomprise polyimide, polyesters, teflon or the like to insulate adjoiningdetectors 428 and/or electrodes 424.

In one embodiment, a temperature sensor 430 is disposed at or near thedistal end of body 412, and a proximal temperature sensor 432 isdisposed proximal to electrodes 424. Temperature sensors 430 and 432 maycomprise thermocouples, thermistors or the like within the scope of thepresent invention. In an alternative embodiment, temperature sensor 432is replaced with a tip electrode. In this manner, the distal tip ofelongate body 412 may be used for mapping and/or ablation procedures.

In one embodiment, electrodes 424 are adapted for a tissue mappingfunction. In a particular embodiment, electrodes 424 are adapted foronly a tissue mapping function, and may be sized accordingly. Forexample, electrodes 424 may comprise ring electrodes. In such anembodiment, electrodes 424 may have a smaller exposed outer surface 436than similar ablation electrodes. In a particular embodiment, electrodes424 further include an inner surface 434, which facilitates electricalcoupling to a controller by having a wire or wires (not shown) extendingthrough lumen 439. In this manner, the catheter of FIGS. 12A and 12B isadapted for tissue mapping and tissue orientation functions, andoptionally, tissue ablation. Tissue imaging also may be included.

The invention has now been described in detail. However, it will beappreciated that certain changes and modifications may be made. Forexample, while FIGS. 2, 3, 5 and 8 depict transducer elements 28interspaced between all ablation elements 24, transducers 28 may onlyexist between some of ablation elements 24 and in some gaps 26.Therefore, the scope and content of this invention are not limited bythe foregoing description. Rather, the scope and content are to bedefined by the following claims.

1. A method of precisely positioning a medical catheter with respect toa tissue, the method comprising: providing a medical catheter systemcomprising: a flexible elongate body having a proximal end and a distalend; a plurality of spaced apart electrodes operably attached to theflexible body near the distal end, wherein at least one of the pluralityof electrodes is adapted only for mapping a tissue such that said atleast one electrode adapted only for mapping a tissue has an exposedouter surface area smaller than a similarly configured ablationelectrode; a plurality of tissue orientation detectors disposed on theflexible body between at least some of the electrodes; and a controllerelectrically coupled to the plurality of electrodes and the plurality oftissue orientation detectors; inserting the flexible elongate body intoa patient; mapping an electrical profile of the tissue using at leastsome of the plurality of electrodes; positioning the elongate body to beproximate a tissue using the plurality of tissue orientation detectorsand based in part on the electrical profile of the tissue; andactivating at least one of the electrodes to ablate a desired region ofthe tissue if the controller determines that at least one of the tissueorientation detectors is in contact with the desired region.
 2. Themethod as in claim 1 further comprising activating at least one of theelectrodes to ablate a desired region of the tissue if the controllerdetermines that one of the tissue orientation detectors located adjacentthe electrode is in contact with the desired region.
 3. The method as inclaim 1 further comprising activating at least one of the electrodes toablate a desired region of the tissue if the controller determines thatthe tissue orientation detector located directly proximal of theelectrode is in contact with the tissue.
 4. The method as in claim 1further comprising activating at least one of the electrodes to ablate adesired region of the tissue if the controller determines that thetissue orientation detectors closest to the electrode in both theproximal and distal directions are in contact with the tissue.
 5. Themethod as in claim 1 further comprising identifying a desired region ofthe tissue to be treated based on the electrical profile of the tissue.6. The method as in claim 1 wherein the mapping comprises a non-contactmapping.
 7. The method as in claim 1 wherein the tissue orientationdetectors comprise a plurality of transducers.
 8. The method as in claim7 wherein at least some of the plurality of transducers compriseultrasound transducers.
 9. The method as in claim 7 wherein at leastsome of the plurality of transducers comprise electric, magnetic orelectromagnetic transducers.
 10. The method as in claim 1, furthercomprising determining whether at least one of the tissue orientationdetectors is in contact with the desired region by calculating a timedelay of a signal transmitted by, and subsequently received by the atleast one of the tissue orientation detectors.
 11. A method of preciselypositioning a catheter within a patient, the method comprising:inserting a catheter into a patient, the catheter comprising: a flexibleelongate body having a proximal end and a distal end; a plurality ofspaced apart electrodes operably attached to the flexible body near thedistal end, wherein at least one of the plurality of electrodes isadapted only for mapping a tissue such that said at least one electrodeadapted only for mapping a tissue has an exposed outer surface areasmaller than a similarly configured ablation electrode; and a pluralityof transducers disposed between at least some of the electrodes; mappinga tissue of the patient, using at least some of the plurality of spacedapart electrodes, to produce a tissue profile; identifying a tissueregion to be treated using the tissue profile; positioning the elongatebody using the transducers so that at least one of the plurality ofelectrodes is proximate the tissue region; and ablating the tissueregion using at least one of the plurality of electrodes when at leastone of the transducers is ing contact with the tissue region.
 12. Themethod as in claim 11 wherein the tissue profile comprises a pluralityof electrical pathways of the tissue.
 13. The method as in claim 11wherein the positioning comprises a three-dimensional localizationpositioning.
 14. The method as in claim 11 wherein at least some of theplurality of transducers comprise ultrasound transducers.
 15. The methodas in claim 11, further comprising determining whether at least one ofthe transducers is in contact with the tissue by calculating a timedelay of a signal transmitted by, and subsequently received by the atleast one of the transducers.
 16. A method of diagnosing and treatingcardiac rhythm disturbances, the method comprising: inserting a catheterinto a patient, the catheter comprising: a flexible elongate body havinga proximal end and a distal end; a plurality of spaced apart electrodesoperably attached to the flexible body near the distal end, wherein atleast one of the plurality of electrodes is adapted only for mapping atissue such that said at least one electrode adapted only for mapping atissue has an exposed outer surface area smaller than a similarlyconfigured ablation electrode; and a plurality of spaced apart tissueorientation detectors attached to the flexible body near the distal end;mapping a tissue of the patient, using at least some of the plurality ofspaced apart electrodes, to produce a tissue profile; identifying atissue to be treated using the tissue profile; positioning the elongatebody using the tissue orientation detectors so that at least one of theplurality of electrodes is proximate the tissue to be treated; andablating the tissue using at least one of the electrodes when at leastone of the tissue orientation detectors is in contact with the tissue.17. The method as in claim 16, further comprising determining whether atleast one of the tissue orientation detectors is in contact with thetissue by calculating a time delay of a signal transmitted by, andsubsequently received by the at least one of the tissue orientationdetectors.
 18. A method of precisely positioning a medical catheter withrespect to a tissue, the method comprising: providing a medical cathetersystem comprising: a flexible elongate body having a proximal end and adistal end; a plurality of spaced apart electrodes operably attached tothe flexible body near the distal end; a plurality of tissue orientationdetectors disposed on the flexible body between at least some of theelectrodes; and a controller electrically coupled to the plurality ofelectrodes and the plurality of tissue orientation detectors; insertingthe flexible elongate body into a patient; mapping an electrical profileof the tissue using at least some of the plurality of electrodes;positioning the elongate body to be proximate a tissue using theplurality of tissue orientation detectors and based in part on theelectrical profile of the tissue; and activating at least one of theelectrodes to ablate a desired region of the tissue if the controllerdetennines that the tissue orientation detectors closest to theelectrode in both the proximal and distal directions are in contact withthe tissue.
 19. A method of precisely positioning a medical catheterwith respect to a tissue, the method comprising: providing a medicalcatheter system comprising: a flexible elongate body having a proximalend and a distal end; at least one electrode operably attached to theflexible body near the distal end and adapted for mapping a tissue; atleast one tissue orientation detector disposed on the flexible bodyadjacent the electrode; and a controller electrically coupled to the atleast one electrode adapted for tissue mapping; inserting the flexibleelongate body into a patient; mapping an electrical profile of thetissue using the at least one electrode adapted for tissue mapping;positioning the elongate body to be proximate a tissue using the tissueorientation detector and based in part on the electrical profile of thetissue; and activating at least one electrode to ablate a desired regionof the tissue if the controller determines that the tissue orientationdetector is in contact with the desired region.
 20. The method as inclaim 19 further comprising activating at least one electrode to ablatea desired region of the tissue if the controller determines that thetissue orientation detector located directly proximal of the electrodeis in contact with the tissue.
 21. The method as in claim 19 furthercomprising activating at least one electrode to ablate a desired regionof the tissue if the controller determines that the tissue orientationdetector closest to the electrode in both the proximal and distaldirections are in contact with the tissue.
 22. The method as in claim 19further comprising identifying a desired region of the tissue to betreated based on the electrical profile of the tissue.
 23. The method asin claim 19 wherein the mapping comprises a non-contact mapping.
 24. Themethod as in claim 19 wherein the tissue orientation detector comprisesa plurality of transducers.
 25. The method as in claim 24 wherein atleast some of the plurality of transducers comprise ultrasoundtransducers.
 26. The method as in claim 24 wherein at least some of theplurality of transducers comprise electric, magnetic or electromagnetictransducers.
 27. A medical catheter system comprising: a flexibleelongate body having a proximal end and a distal end; a plurality ofspaced apart electrodes operably attached to the flexible body near thedistal end and adapted for mapping a tissue; a plurality of tissueorientation detectors disposed on the flexible body, wherein at leastone of the tissue orientation detectors is disposed between two of theelectrodes adapted for tissue mapping; at least one electrode adaptedfor ablating tissue disposed on the flexible body and adjacent one ofthe tissue orientation detectors; a controller coupled to the electrodesadapted for mapping a tissue and coupled to the tissue orientationdetectors wherein the controller is adapted for tissue mapping; and anindicator light adapted to indicate when the tissue orientation detectoris in contact with tissue.